EBME Forums Forums Management Medical Equipment Management PPM Schedule

Good Afternoon All,

Looking for an official document that indicated that there is a 30 day window from the due date of a PPM until the completion. This is proving very difficult, is there an actual 'official' document that allows up to 30 days for a PPM to be completed after the due date?

It would not surprise me if such an edict has been issued somewhere in the world; it is the sort of thing that is sometimes hidden in portrayals of "ideal procedures to be aimed for" dreamt up by "certain international bodies" (but sadly rarely implemented, and even more rarely carried on once original enthusiasm has petered out).

I look forward to reviewing this document should you track it down, Neil.

At this stage, I would only comment:- let's hope that there is some sort of linkage between the Office of Good Ideas that come up with stuff like this and the authorisation of extra resources needed to carry them out.

Wow!
Would have thought that there would have been a bigger response than 1 reply.
As this is a site for EBME, can anyone come up with an answer, extending the PPM beyond the recommendation and guidelines of the manufacturer could have legal consequences.

Where did you pick up this rumour, Neil; could it be a "Chinese whisper", I wonder?

It sounds to be more like a clause in an agreement with a service contractor.

No doubt you and I both recall the financial penalties that could be applied if Work Orders were not "actioned" within agreed (contractual) time frames (sometimes thirty days). OK, not PM ... but a more useful metric, I would suggest.

"Action" was generally evidenced by a recorded (documented) visit or (better yet) by parts being ordered to remedy the fault. If we were able to close the Work Order (as was usually the case), then so much the better.

I'm not aware of any official documents that cover the 30 day window.

It would be a really difficult one to apply a standard document to all devices that we deal with.

eg A ventilator that was new, in storage for 11 months then put into clinical use for a month - is the PPM due in one month or 12 months from the first clinical use date? The warranty would certainly be from the purchased date but if it's not been used why change parts?

There are so many variables in this line of work as I'm sure we're all aware.

Personally, i would carry out a risk assessment on each device documenting the implications if parts were not replaced as per the technical manual - that in itself is a lot of work as each parts lifespan would have to be taken into account and again it would depend on clinical use, so not easy. But from a legal point of view it shows we have assessed the situation and documented something!

The less detail the better - keeping it simple and vague is often the best way!

eg A ventilator that was new, in storage for 11 months then put into clinical use for a month - is the PPM due in one month or 12 months from the first clinical use date? The warranty would certainly be from the purchased date but if it's not been used why change parts?

It would be extremely irresponsible to take any equipment especially a ventilator out of storage and put it into clinical use without performing a full service, regarding a risk assessment this has already been completed by the OEM hence the service periods that they give for their equipment.

You may have also noticed that the OEM does not state 12 months plus 30 days.

It does appear that the '30 days' is a BME myth.

The risk assessment the OEM would have produced is different to what I was referring.

Perform a local risk assessment on the implications of not changing a part for over 30 days. eg A battery - what are the dangers if is not replaced as per the maintenance schedule in the tech manual.

This could depend on the area the device is used in, if the clinical area has UPS back up, is the device solely used on battery or is it just back up, the age of the battery etc

Produce a document that details the risks to show how you came to a decision.

On the 12 months plus 30 days point - is that 12 months from when the device was delivered? Was assembled and tested? Was first put into clinical use?

Indeed. And furthermore, all torturous debate (especially that of the "dancing on the head of a pin" variety) is readily overcome by the diligent application of "Risk-Based PM".

See many earlier threads surrounding that issue.

When it comes to in-house tech support, what matters is the condition of each item. That is:- is it fit to meet the needs of the user(s)? That should be the over-riding consideration.

This applies at all stages of the equipment life-cycle:- namely from acquisition, through the (hopefully long) years of in-service use, all the way to condemnation and/or disposal.